NDC 63304-452
Morphine sulfate 100 mg tablet, film coated, extended release
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Noramco, LLC | Wilmington, DE, United States | Makes the active ingredient | Problems found, fixed voluntarilyOct 15, 2025 · 8 inspections |
| Ohm Laboratories Inc. | New Brunswick, NJ, United States | Makes it | No problems foundOct 31, 2024 · 22 inspections |
Recalls
- Feb 6, 2025 · Class II · Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications
Lots: Lot #: AD16615, Exp. Date 07/2025
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Morphine: every company that makes it
- Form
- tablet, film coated, extended release, oral
- Strength
- 100 mg
- Approval
- ANDA ANDA078761
- On the market since
- May 11, 2012
- Package NDCs
63304-452-0163304-452-0363304-452-05- Official label
- DailyMed (National Library of Medicine), updated Mar 15, 2026
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